guidance for the use of zuclopenthixol acetate …

GUIDANCE ON THE USE OF CLOPIXOL ACUPHASE _PHA11_AUGUST 2020

GUIDANCE FOR THE USE OF ZUCLOPENTHIXOL ACETATE (CLOPIXOL ACUPHASE) IN ADULTS

AUGUST 2020

This policy supersedes all previous Guidance for the use of clopixol acuphase (zuclopenthixol acetate) in adults.

GUIDANCE FOR THE USE OF CLOPIXOL ACUPHASE_PHA11_AUGUST 2020 i

Policy title Guidance for the use of zuclopenthixol acetate (clopixol acuphase) In adults

Policy reference

PHA11.

Policy category Clinical - Medicines

Relevant to All Trust Staff involved in the use of zuclopenthixol acetate (clopixol acuphase).

Date published August 2020.

Implementation date

August 2020.

Date last reviewed

August 2020

Next review date

May 2023.

Policy lead Lucy Reeves, Chief Pharmacist.

Contact details Email: [email protected] Telephone: 020 7288 5093.

Accountable director

Dr Vincent Kirchner, Medical Director.

Approved by (Group):

Drugs And Therapeutics Committee.

Approved by (Committee):

Quality Committee.

Document history

Date Version Summary of amendments

Mar 2008 1 New Guidelines

Mar 2011 2 Routine review

Mar 2013 3 Routine review

Feb 2015 4 Routine review

May 2017 5 Routine review

May 2019 6 Routine review

August 2020

7 Routine review

Membership of the policy development/ review team

Dr Neil Sarkar, Consultant Psychiatrist, Dr Neil Stewart, Consultant Psychiatrist, Dr James Dove, Higher Trainee, Audrey Coker, Lead Pharmacist for Clinical Services.

Consultation

Drugs And Therapeutics Committee Members

DO NOT AMEND THIS DOCUMENT

Further copies of this document can be found on the Trust intranet.

GUIDANCE FOR THE USE OF CLOPIXOL ACUPHASE_PHA11_AUGUST 2020 ii

Contents Page

1 Introduction 1

2 Aims and objectives 1

3 Scope of the policy 1

4 Zuclopenthixol acetate and the mental health act 1

5 Indication 2

6 Assessment prior to consideration of zuclopenthixol acetate 2

7 Long term management 5

8 Dosage and administration 5

9 Physical monitoring 5

10 Equipment 7

11 Management of side effects and complications 8

12 Recording and incident reporting 9

13 Dissemination and implementation arrangements 9

14 Training requirements 9

15 Monitoring and audit arrangements 9

16 Review of the policy 10

17 References 11

18 Associated documents 12

Appendix 1:Treatment algorithm for the use of zuclopenthixol acetate 13

Appendix 2: Schematic diagram to demonstrate suggested dosing Schedule

14

Appendix 3: Practice guidance for the use of lorazepam injection 15

Appendix 4: Equality impact assessment tool 16

GUIDANCE FOR THE USE OF CLOPIXOL ACUPHASE_PHA11_AUGUST 2020 1

1. Introduction

Zuclopenthixol Acetate (ZA or ‘Clopixol Acuphase’) is an injectable anti-psychotic licensed for the short term treatment of acute psychosis, mania and exacerbation of chronic psychosis1. It is not part of the group of medicines used for rapid tranquilisation. It is commonly used for management of significantly violent and aggressive behaviour in these contexts when the person represents a risk of harm to themselves and/or others and where repeated doses of injectable anti psychotics and/or sedatives have been required2. Research to date has shown that the primary impact of implementing ZA administration in the acutely disturbed patient is to reduce the number of injections required overall in their course of treatment. This guideline gives a practical guide to the safe use of ZA and when to consider it. It is not a recommendation for its use, and first line recommendation is always the non-pharmacological approach to anticipating and minimising the emergence of dangerously disturbed behaviour. Proactive and assertive treatment of an underlying disorder (e.g. psychosis), as well as pre-empting adverse environmental factors (e.g. interpersonal conflict) may prevent the situation arising in the first place. The use of medication should not be seen as the first and only response to the management of disturbed violent patients, but rather as one aspect of the total plan of management with contributions from all members of the multidisciplinary team. The use of zuclopenthixol acetate is not a first line treatment option in managing violent and aggressive behaviour.

2. Aims and objectives

To provide guidance to prescribers and nursing staff on the safe, effective and appropriate use of zuclopenthixol acetate in acutely disturbed patients.

3. Scope of the guideline

This policy is aimed at all clinical, nursing and medical staff, who are directly involved in the management of acutely disturbed patients. The guidance covers the prescribing and administration of zuclopenthixol acetate to service users from the age of 18 in inpatient settings. Zuclopenthixol acetate should not be prescribed or administered to outpatients.

4. Zuclopenthixol acetate and the Mental Health Act

This guideline aims to ensure zuclopenthixol acetate is administered to patients in line with current NICE guidance and best practice recommendations. Administration of zuclopenthixol acetate should be undertaken in accordance with the Mental Health Act Code of Practice (DH, 2015). This policy complies with the Code of Practice3. It also takes into account 'Positive and Proactive Care: Reducing the need for restrictive interventions'(DH, 2014). In line with ‘Positive and proactive care...’(DH, 2014)4 use of zuclopenthixol acetate should be a last resort. Those patients for whom zuclopenthixol acetate might be used should have comprehensive behavioural support plans, detailing the range of strategies for dealing with disturbed behaviour that may be used as less restrictive options. These should be followed.


The use of restrictive interventions must take place only under appropriate legal authority. Use of restraint implies that the person is not consenting to treatment. Informal patients should not be restrained. If a patient is not detained, but restraint in any form has been deemed necessary (whether as an emergency or as part of the patient’s treatment plan), immediate consideration should be given to whether formal detention under the Act is appropriate (subject to the criteria being met). Where a patient is deprived of liberty in a hospital for mental health treatment under the deprivation of liberty safeguards in the MCA, the use of restraint may well indicate that the patient objects to treatment or to being in hospital. The patient is therefore no longer eligible to be held under those safeguards. If so, consideration will need to be given to whether the patient can and should be detained under the Mental Health Act instead. The decision to use restraint should first be discussed with the clinical team and must be recorded in the patient’s EPR (Care Notes), along with the justification for it. An incident form must also be completed.

5. Indication

Zuclopenthixol acetate injection is licensed for the short term management of acute psychosis, mania or exacerbations of chronic psychosis, but does not treat the underlying condition. NICE does not recommend its use for rapid tranquilisation due to long onset and duration of action. However, zuclopenthixol acetate injection may be considered as an option for disturbed behaviour when:

More than 2 injections of immediate release antipsychotic medicines and/or sedatives have been required to manage a person’s behaviour.

A person is refusing oral mental health medicines.

It is clearly expected that the service user will be disturbed/violent over an extended period of time.

A service user has a past history of good and timely response to zuclopenthixol acetate injection2.

A service user has a past history of repeated parenteral injection2.

An advance directive has been made indicating that this is a treatment choice.

It should never be administered to those without any previous exposure to antipsychotic medication. The BNF and manufacturer’s Summary of Product Characteristics (SPC) should be consulted regarding its use5,6. If shorter acting parental medicines (i.e. lorazepam, haloperidol, aripiprazole) have already been administered for rapid tranquillisation, then sufficient time must be allowed to assess the full response to these medicines before zuclopenthixol acetate is administered. This should be at least 60 minutes2 (2 hours if aripiprazole was administered). Zuclopenthixol acetate is not licensed for the treatment of dementia-related behavioural disturbances7.

6. Assessment prior to consideration of zuclopenthixol acetate.

‘Requirements prior to use of ZA’

Zuclopenthixol acetate must only be initiated on the recommendation of a consultant

psychiatrist or an SPR/ST4-6. This must be documented in the patient’s records and

include the rationale for use.


The BNF and manufacturer’s Summary of Product Characteristics (SPC) should be

consulted regarding its use.

Consideration must be given to level of observations to be required following

administration of dose and this clearly documented and communicated to the nursing

team

6.1 The assessment of the patient to ascertain the following. The assessment

must be documented in the EPR.

Zuclopenthixol acetate must only be initiated on the recommendation of a

consultant psychiatrist or an SPR/ST4-6. This must be documented in the

patient’s records and include the rationale for use.

In reaching the decision to use zuclopenthixol acetate, the senior nurse and the consultant psychiatrist or an SPR/ST4-6 should undertake a risk assessment of the situation, including the risks to the patient, other patients, staff and the environment and the patient’s current mental state.

The patient must be informed that zuclopenthixol acetate is going to be given.

Physical health, age and ability to do a physical examination.

Past and current medical history, especially cardiorespiratory disease, organic syndromes, acute confusional states, CNS infection, epilepsy, head injury, advanced renal or hepatic disease, Parkinsons disease and falls. Consider the possibility of a physical examination to ascertain the information including state of hydration, illicit drug intoxication and urine drug screens, delirium, hypoglycaemia, pregnancy8.

Allergies and sensitivities and severity of extrapyramidal side effects.

Recent and current medication.

Medicine interactions are possible with a number of medicines including alcohol, CNS depressants, general anaesthetics, tricyclic antidepressants, antipsychotics, levodopa, metoclopramide, piperazine, lithium salts, and enzyme inhibitors which may result in potentiated QT prolongation. Medicines with particular modes of action that involve electrolyte or fluid disturbances e.g. diuretics may affect blood potassium levels. Hypo- or hyperkalaemia can induce cardiac arrhythmias which can manifest as QT interval prolongation6. Refer to a current copy of the Maudsley prescribing guidelines for a list of medicines associated with QT prolongation2.

This is not an exhaustive list and further information can be obtained from the Pharmacy department or by referring to the current BNF.

The amount of antipsychotic and benzodiazepine medication administered to the patient in the preceding 72 hours.

Recent and chronic use of illicit substances and/or alcohol.

Previous exposure to antipsychotic medication.

Previous response to zuclopenthixol acetate where appropriate.

Current physical observations.

Recent ECG findings, U&Es and LFTs. Every effort should be made to obtain baseline measurements of temperature, blood pressure, pulse rate, respiratory rate and the level of consciousness prior to the administration of zuclopenthixol acetate. A pre-treatment ECG should also be offered if possible. Emergency resuscitation equipment,


procyclidine injection and flumazenil injection must be available before treatment. Ensure the patient is monitored (see table 1 – ‘Observations’). The patient should be able to respond to communication throughout. 6.2 ‘Cautions and considerations prior to use of ZA’:

in an attempt to ‘hasten’ the antipsychotic effect of other antipsychotic therapy2.

for rapid tranquillisation (onset of effect is too slow)2.

at the same time as other parenteral antipsychotics (may lead to over-sedation which is difficult to reverse)2.

as a test dose for zuclopenthixol decanoate depot2. 6.3 Zuclopenthixol acetate should not be used for, or in, the following:

Patients whose physical state gives cause for concern.

Patients who accept oral antipsychotic or benzodiazepines and are adherent.

Patients who are neuroleptic naïve.

Patients who are unconscious or reduced level of consciousness.

Patients acutely intoxicated with drugs or alcohol or concern re: recent use.

Patients who are pregnant.

Patients with organic illnesses.

Patients with dementia related behavioural disturbance

Patients with Parkinson’s disease

Hypersensitivity to ZA

6.4 Zuclopenthixol acetate should be used with caution (and consider alternatives) in the following circumstances (table 1):

If shorter acting parental medicines (i.e. lorazepam, haloperidol, aripiprazole)

have already been administered for rapid tranquillisation, then sufficient time

must be allowed to assess the full response to these medicines before

zuclopenthixol acetate is administered. This should be at least 60 minutes (2

hours if aripiprazole is administered).

Zuclopenthixol acetate is NOT rapid tranquilisation. If more rapid sedation is

required, the administration of IM lorazepam at the same time at the first dose

of zuclopenthixol acetate should be considered, with appropriate

consideration given for potential for over sedation

Patients who are physically struggling and resisting – there is increased risk

of potential intra-venous administration of injectable medication.

Those with defined physical illness – renal, cardiac disease, epilepsy,

respiratory disease, full risk assessment and physical assessment required

with consultation of Summary of Product Characteristics (SPC) online.

Caution advised in those with intellectual disabilities.

Consideration should be exercised as with administration of all antipsychotics

regarding stroke and cardiac risk.


7. Long term management

Treatment with zuclopenthixol acetate should not extend beyond a two week period4. During that time a long term treatment plan should be put in place. Summary product characteristics (SPC) should be consulted online for guidance around starting oral anti-psychotics after administration of ZA. If considering depot anti-psychotic administration as long term treatment plan for person receiving ZA then consideration should be given to co-administration of Zuclopenthixol decanoate depot in co-administration with final (likely third) injection of ZA. This approach is licensed by the BNF and full monograph of product characteristics for zuclopenthixol decanoate9,10,11.

Advice can be obtained from the Pharmacy department for individual cases.

8. Dosage and administration 8.1 Dose (adults 18-60 years). 50-150mg by deep intramuscular injection (in the upper outer buttock or lateral thigh), repeated if necessary after two to three days7. Maximum of 400mg in a two week period. The number of injections should not exceed four.2 The injections should be spaced at least twenty-four hours apart2. There is no such thing as a course of ‘Acuphase’. The patient should be assessed before each individual dose is prescribed and administered2. 8.2 Dose (elderly) The dosage may need to be reduced in the elderly due to reduced rates of metabolism and elimination. Maximum dosage per injection should be 100mg7.

Zuclopenthixol acetate should be prescribed as stat doses. ‘As required’ prescriptions are not acceptable given the need for patient assessment by medical staff prior to administration of each dose.

THE MAXIMUM LICENSED DOSE REGIME SHOULD NOT BE EXCEEDED. 8.3 Administration by deep intramuscular injection only.

8.4 Onset and duration of action.

Onset: Sedative effects usually begin to be seen two hours after the injection

with an estimated peak at 8 hours.

Peak of anti-psychotic action: 24-48 hours12.

Duration of action of first injection: seventy-two hours.

9.0 Physical monitoring

After administration of zuclopenthixol acetate

9.1 Intermittent (every half an hour) visual observation should be used for seventy two hours after each dose. Observations should be documented in the patients’ EPR.


Monitor the patient for extrapyramidal or any other side effects. Every effort should be made to obtain baseline measurement of temperature, blood pressure, pulse rate, respiratory rate and level of consciousness prior to administration. All patients receiving zuclopenthixol acetate must be physically monitored following administration as below and documented on the NEWS monitoring chart and in the EPR. Refusals should be documented.

Table 1: Observations

Prior to Administration

TPR, BP, degree of hydration, level of consciousness, oxygen status if asleep. Where possible, obtain Us & Es, LFTs including GGT and an ECG.

Post administration

Patients must receive intermittent (every fifteen minutes) or enhanced observations (one to one). Observations must be carried out for a minimum of three days post each dose of zuclopenthixol acetate.

In addition, an attempt must be made to obtain a full set of vital signs a minimum of four times a day. The frequency may be increased depending on clinical need. Vital signs must be carried out for a minimum of three days post each dose of zuclopenthixol acetate.

If lorazepam injection is given with the first dose of zuclopenthixol acetate

Patients must receive intermittent (every fifteen minutes) or enhanced observations (one to one). Observations must be carried out for a minimum of three days post each dose of zuclopenthixol acetate.

Attempts must be made to made to monitor vital signs:- Every hour for four hours or Every fifteen minutes for four hours if specific criteria apply After four hours, attempts must be made obtain a full set of vital signs a minimum of four times a day.

Any clinical concerns should be discussed with the medical staff. Thereafter, monitoring should be carried out as above and any clinical concerns discussed with the medical team. Observations and vital signs must be documented. Where monitoring is offered and refused, this should be documented in the EPR and the NEWs chart.

Emergency resuscitation equipment, procyclidine injection and flumazenil injection must be available before treatment.

Fluid balance & electrolyte balance should be monitored as clinically indicated and documented.

ECG monitoring – an ECG should be offered when the patient is calm.

If a patient is unconscious the airway must be protected. Continuous pulse oximetry is recommended to monitor oxygen levels. The level of alertness and respiratory effort should be assessed by attempting to wake a sleeping patient. Unconscious patients must not be secluded and must be observed by an appropriately trained member of staff at all times.

Seclusion: When a patient is in seclusion a nurse must constantly observe the patient using either direct observation or audio-visual equipment. At a minimum, every hour the patient’s respiratory rate and level of consciousness must be monitored through the window of the seclusion room. These observations must be documented. Staff must enter the seclusion room once every two hours to perform a seclusion review to assess the patient


and decide on whether continued seclusion is needed. Staff must attempt to make physical observations (heart rate, temperature, oxygen saturations, blood pressure and level of consciousness) at each seclusion review. The nurse responsible for directly observing the patient throughout the period of seclusion is responsible for initiating an earlier than planned review if any concerns about the patient’s physical welfare arise. If any urgent concerns about a patient’s physical health arise then seclusion must be terminated immediately. Unconscious patients must not be secluded and must be observed by an appropriately trained member of staff at all times.

In the following circumstances, more frequent monitoring and intensive monitoring may be required: The patient appears to be or is asleep / sedated. The BNF limit is exceeded. An older adult’s mobility is affected or they are at risk of falls. The patient has been recently misusing substances or alcohol.

9.2 The administration and monitoring of zuclopenthixol acetate should be discussed at handover meetings and feedback to the ward doctor and at ward round. 9.3 Caution should be exercised if seclusion is used following zuclopenthixol acetate. If the patient is asleep, then ‘seclusion’ ends. The door should be left open and the patient observed on a ‘one to one’ basis6. 9.4 The individual should be reviewed by a doctor at the earliest opportunity, but within twenty four hours of receiving zuclopenthixol acetate. 9.5 An ECG should be offered to patients after administration of zuclopenthixol acetate if there is no recent record. This should be done when the patient is calm. Consider conducting an ECG following the administration of zuclopenthixol acetate if the following apply:

High doses are used.

When used in combination with any other medicines known to prolong the QTc interval (see the Maudsley prescribing guidelines).

If the baseline ECG was abnormal or a baseline ECG was not available.

If there was any clinical indication to repeat the ECG13.

9.6 Consider checking electrolytes if not checked within the last three to four days13.

9.7 Check for signs of dehydration e.g. thirst, dry mouth, lips and a reduction in urine

output13.

10.0 Equipment

The following equipment should be available in all settings where zuclopenthixol acetate may be given (are stored):

Pulse oximeters.

ECG machines should be available on site.

A grab bag, automatic external defibrillator and oxygen must be available and easily accessible. This equipment should be maintained and checked in


accordance with the Trust cardiopulmonary resuscitation (CPR) policy and staff should be familiar with their use.

First-line resuscitation medicines should be available. Procyclidine injection should be available.


11.

TABLE 3: Management of side effects and complications

COMPLICATION SYMPTOMS/SIGNS MANAGEMENT

Acute dystonia

Severe painful muscular stiffness and/or oculogyric crisis.

Procyclidine 5-10 mg i.m2,14

. Repeat after twenty minutes if necessary

8. If not severe, syrup may be given.

Hypotension

Fall in blood pressure (30mmHg orthostatic drop or <50mmHg diastolic)

2,4.

Lie patient flat and raise legs2.

Monitor closely2.

Neuroleptic Malignant Syndrome (NMS)

Increasing temperature, fluctuating blood pressure, tachycardia, incontinence/retention, sweating, muscular rigidity or confusion/altered consciousness

2.

Call the duty doctor or the ward doctor immediately. Withhold antipsychotics. Monitor closely. Send bloods for the creatine phosphokinase level

2.

Arrhythmias

Slow (<50/minute) or irregular pulse

2.

Call the duty doctor or the ward doctor immediately1.

An ECG should be done. Withhold antipsychotics. Monitor closely.

Respiratory depression

Reducing respiratory rate, reducing consciousness.

Call an ambulance via 999. Call the duty doctor or the ward doctor immediately Bring the resuscitation equipment. Give oxygen, if patient able to sit upright, this will assist breathing. If unconscious, position in “recovery position” and protect the airway. Give oxygen. If respiratory rate drops below 10/minute or Oxygen Saturation <90%

2,14, consider manual ventilation after inserting an airway if

necessary. If patient received benzodiazepines, use flumazenil

1.

(May rarely cause seizures in benzodiazepine dependant patients, in epileptic patients or those with head injuries). How to give flumazenil: 1. 200mcg i.v. over 15 seconds. 2. If consciousness not resumed within 60 seconds give 100mcg

IV over 10 seconds. 3. Repeat at 60 second intervals. Maximum dose 1mg/24 hour

2.

Continue to monitor after respiratory rate returns to normal. Flumazenil has a short duration of action so further doses may be required as above

15. Patients may become agitated or anxious on

wakening.

If respiratory depression is induced by other agent patient will require mechanical ventilation

2 – obtain emergency medical

assistance.


12. Recording and incident reporting

The use of zuclopenthixol acetate should be reported in the patient’s EPR and on a datix

electronic incident reporting form if the use of control and restraint was required. There

should be a full multidisciplinary review after the event.

13. Dissemination and implementation arrangements

This document will be circulated to all managers who will be required to cascade the information to members of their teams and to confirm receipt of the procedure and destruction of previous procedures/policies which this supersedes. It will be available to all staff via the Trust intranet. Managers will ensure that all staff are briefed on its contents and on what it means for them.

14. Training requirements

Medicines Management Training for Nurses is provided to Nurses once a year on each site. There is a junior doctors’ induction programme which signposts key prescribing procedures and medicines management policies. There is also access to the policy folder on the Trust intranet via the induction package.

15. Monitoring and audit arrangements

Elements to

be monitored

Lead How trust will monitor

compliance

Frequency

Reporting arrangements

Acting on recommendations and Lead(s)

Change in practice and lessons to be shared

Prescribing

Chief Pharmacist

Audit: as part of RT audit. Clinical Pharmacy prescription monitoring

Annually Ongoing

Drugs & Therapeutics Committee, Quality Committee

Required actions will be identified and completed in a specified timeframe

Required changes to practice will be identified and actioned within a specific time frame. A lead member of the team will be identified to take each change forward where appropriate. Lessons will be shared with all the relevant stakeholders.

Administration

Director of Nursing / Chief Pharmacist


Annually Ongoing



Monitoring

Director of Nursing / Chief Pharmacist


Annually Ongoing




16. Review of the policy

Review date: 3 years


17. References

1. Cochrane review 2012 is primary resource for all

https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD000525.pub3/full#0

2. The South London and Maudsley NHS Foundation Trust; Oxelas NHS Foundation Trust. Prescribing Guidelines. 13th Edition. Taylor D., Barnes T.R.E. and Young A.H.

3. Department of Health. Code of Practice; Mental Health Act 1983. London. The Stationery Office. 2008. ISBN 978 0 11 3230068.

4. Department of Health. Positive and proactive care: reducing the need for restrictive

interventions. (April 2014) (online). Available:

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attac

hment_data/file/300293/JRA_DoH_Guidance_on_RP_web_accessible.pdf

(accessed 6th of April 2019).

5. British National Formulary. Number 78. London. BMJ Group and Pharmaceutical

Press. September 2019

6. NICE 2015. Violence and aggression – short-term management in mental health,

health and community settings. NICE Clinical Guideline No. 10 National Institute for Health and Clinical Excellence http://www.nice.org.uk/guidance/ng10. At https://www.nice.org.uk/guidance/ng10.

7. Lundbeck Ltd. The specification of product characteristics . Clopixol acuphase

injection Injection (May 2020). (online). Available: https://www.medicines.org.uk/emc/medicine/1071 (accessed July 2020)

8. Devonshire Partnership NHS Trust. Protocol for prescribing and administration of

injectable drugs for rapid tranquillisation (RT), physical health assessment and monitoring, including prescribing guidelines on the drugs to be used for RT. May 2012. http://www.devonpartnership.nhs.uk/uploads/tx_mocarticles/C36_CP11-ProtocolForRapidTranquilisation_Jul12.pdf (accessed 19th January 2013).

9. https://www.sussexpartnership.nhs.uk/sites/default/files/documents/clopixol_acuphase_guidance_-_v4_-with_news_chart_-_mar_19.pdf

10. Tew (Tees Esk and WEIR) https://www.tewv.nhs.uk/content/uploads/2018/10/Clopixol-Acuphase-Guidelines-for-the-use-of-1.pdf

11. Oxford health:

a. The Multi-disciplinary team should consider withholding other antipsychotics

for the duration of action of the zuclopenthixol acetate (72 hours).

b. (Algorithm included)

c. http://www.oxfordhealthformulary.nhs.uk/docs/Acuphase%20Guidelines%202

014_Final.pdf

12. Lundbeck full monograph of product characteristics for clopixol – oral, depot and acuphase 2016: https://www.lundbeck.com/upload/ca/en/files/pdf/pm/Clopixol.pdf



https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/300293/JRA_DoH_Guidance_on_RP_web_accessible.pdf

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/300293/JRA_DoH_Guidance_on_RP_web_accessible.pdf

http://www.nice.org.uk/guidance/ng10

https://www.nice.org.uk/guidance/ng10

https://www.medicines.org.uk/emc/medicine/1071

https://www.sussexpartnership.nhs.uk/sites/default/files/documents/clopixol_acuphase_guidance_-_v4_-with_news_chart_-_mar_19.pdf

https://www.sussexpartnership.nhs.uk/sites/default/files/documents/clopixol_acuphase_guidance_-_v4_-with_news_chart_-_mar_19.pdf

https://www.tewv.nhs.uk/content/uploads/2018/10/Clopixol-Acuphase-Guidelines-for-the-use-of-1.pdf

https://www.tewv.nhs.uk/content/uploads/2018/10/Clopixol-Acuphase-Guidelines-for-the-use-of-1.pdf

http://www.oxfordhealthformulary.nhs.uk/docs/Acuphase%20Guidelines%202014_Final.pdf

http://www.oxfordhealthformulary.nhs.uk/docs/Acuphase%20Guidelines%202014_Final.pdf

https://www.lundbeck.com/upload/ca/en/files/pdf/pm/Clopixol.pdf


13. Northamptonshire healthcare NHS Foundation Trust. Rapid tranquillisation policy. May 2012. http://www.nht.nhs.uk/mediaFiles/downloads/50106872/MMP011%20Rapid%20Tranquillisation%20Policy%20(%20May12-May13).pdf (accessed 19th January 2013.).

14. Macpherson R. et al. A growing evidence base for management guidelines. Revisiting….Guidelines for the management of acutely disturbed psychiatric patients. Advances in Psychiatric Treatment. 2005.11, p404-415.

15. Hameln Pharmaceuticals Ltd. The specification of product characteristics. Flumazenil injection (1st April 2020). (online). Available: https://www.medicines.org.uk/emc/product/6300/smpc (accessed July 2020).

16. Pfizer Ltd. The specification of product characteristics. Ativan injection (February 2019) (online). Available: https://www.medicines.org.uk/emc/medicine/2196 (accessed July 2020).

18. Associated documents

Rapid Tranquillisation Policy’.

Therapeutic Management of Violence And Aggression Policy.

Seclusion Policy.

Observation and Engagement Policy.

http://www.nht.nhs.uk/mediaFiles/downloads/50106872/MMP011%20Rapid%20Tranquillisation%20Policy%20(%20May12-May13).pdf

http://www.nht.nhs.uk/mediaFiles/downloads/50106872/MMP011%20Rapid%20Tranquillisation%20Policy%20(%20May12-May13).pdf

https://www.medicines.org.uk/emc/product/6300/smpc

https://www.medicines.org.uk/emc/medicine/2196


Appendix 1; Treatment algorithm for the use of zuclopenthixol acetate

Treatment algorithm for use of zuclopenthixol acetate to be used for patient once all behavioural management, de-escalation protocols and environmental factors have been worked through:

Attempt ECG – if not possible consider risk as MDT before proceeding

YES

NO

YES

YES

Does person have confirmed or suspected psychotic illness and is significant levels of agitation and aggression with risk to self +/- others?

Does the person meet any of the exclusion criteria set out in protocol

Have they had > 2 injections of anti-psychotic and/or sedative?

Is the person refusing oral medication?

Treatment as usual

Treatment as usual* with RT and oral medication



Is there a recent ECG?

Day 1: Consider initial dose of Zuclopenthixol Acuphase at 75mg+/- 25mg at least 60 minutes after the last dose of any other sedative medications Monitor for at least 24 hours as per protocol and withhold other antipsychotics but use rapid tranquilisation protocols as needed to manage acutely disturbed behaviour. Repeat/ re-attempt ECG Make clinical plan for likely long term anti-psychotic medication after ZA – depot? Oral? Day 3: Administer second dose Zuclopenthixol Acuphase at 100mg +/- 25mg at least 60 minutes after the last dose of any other sedative medications. Day 5: Administer third dose Zuclopenthixol Acuphase at c. 150mg +/- 25mg at least 60 minutes after the last dose of any other sedative medications. Consider co-administration of zuclopenthixol decanoate (Clopixol depot) with final dose of ZA

***TOTAL DOSE IN 2 WEEKS NOT TO EXCEED 400mg***

*Treatment as usual – consider, does the person have REGULAR sedation prescribed, up to BNF max dose clonazepam (Consider liquid) and promethazine. Consider prescribing IM anti-psychotic to be given ROUTINELY IF refusing oral -

aripiprazole or haloperidol depending on ECG status

Consider commencing

oral anti-psychotic

management plan

depending on history and

levels of aggression

Accepting oral medication?

Accepting oral medication?

NO

NO

YES

YES

NO

NO


Appendix 2

Schematic to demonstrate suggested dosing schedule

Figure 1: Indicative illustration of serum concentrations of antipsychotic over course of administration of rapid tranquilisation with haloperidol, implementation of zuclopenthixol acetate (ZA) and commencement of zuclopenthixol decanoate (ZD) suggested regime

Figure 2: indicative illustration of serum concentration of zuclopenthixol acetate following administration

Day 1

Day 3

Day 5


Appendix 3

Practice guidance for the use of lorazepam injection Place in Therapy: • Lorazepam IM is the preferred first line option in most circumstances. • It is a short acting benzodiazepine, therefore carries the least risk of accumulation on repeated dosing. • Attention should be paid to the patients’ total daily dose of benzodiazepine. • In overdose the effect of benzodiazepines can be reversed by flumazenil. Situations where administration is not recommended: • Avoid in patients who are tolerant to benzodiazepines. • Solutions of lorazepam should not be used if they are discoloured or contain a precipitate, or have been outside of refrigeration ((2°C to 8°C) for >30minutes. Dosing in adults • Single dose is 1.5-2.5mg2 as a single intramuscular (IM) injection (at the same time the first dose of zuclopenthixol acetate is given). A repeat dose is not recommended if used in conjunction with zuclopenthixol acetate. Dosing in older adults Single dose is 250micrograms -1mg as a single intramuscular (IM) injection. A repeat dose is not recommended if used in conjunction with zuclopenthixol acetate. Side effects of the injection formulation: • Hypersensitivity reactions, anaphylactic/oid reactions, angioedema are rare. • Rarely, pain and redness have been reported after lorazepam injection. • Respiratory depression may occasionally occur. • The extent of respiratory depression is dose dependent. • Hypotension may occasionally occur. Formulation and Administration: • Lorazepam injection must be stored in a refrigerator (2°C to 8°C)11. After removing from the refrigerator, the injection should be used within 30 minutes. • Solutions of lorazepam should not be used if they are discoloured or contain a precipitate. • Lorazepam is a clear concentrated solution of 4mg/1ml in a 2mL ampoule. • It must be diluted 1:1 with WFI or 0.9% NACL before IM injection11 as the excipients can cause pain if administered undiluted. • Administer by deep intramuscular injection, routinely water for injections should be used • After dilution, gently mix the contents thoroughly. To avoid air bubbles, do not shake vigorously. • Administer immediately after reconstitution. • NEVER mix medicines in the same syringe. • Lorazepam solution for injection is slightly viscid when cool. • Any unused solution should be disposed of as clinical waste. Other Medicines: • Simultaneous injection of IM benzodiazepines is not recommended with IM olanzapine. Summary: • The product does not have a good stability profile and begins to degrade quickly at room temperature, with the risk of precipitation. (Adapted from the monograph in the Trust rapid tranquillisation guidelines).


Appendix 4

Equality impact assessment tool

Yes/No Comments

1. Does the policy/guidance affect one group less or more favourably than another on the basis of:

Race No

Ethnic origins (including gypsies and travellers)

No

Nationality No

Gender No

Culture No

Religion or belief No

Sexual orientation including lesbian, gay and bisexual people

No

Age No

Disability - learning disabilities, physical disability, sensory impairment and mental health problems

No

2. Is there any evidence that some groups are affected differently?

No

3. If you have identified potential discrimination, are any exceptions valid, legal and/or justifiable?

N/A

4. Is the impact of the policy/guidance likely to be negative?

No

5. If so can the impact be avoided? N/A

6. What alternatives are there to achieving the policy/guidance without the impact?

N/A

7. Can we reduce the impact by taking different action?

N/A

guidance for the use of zuclopenthixol acetate …

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